Staple cartridge comprising a releasable adjunct material

ABSTRACT

A surgical stapling apparatus is disclosed which comprises cartridge body and a layer. The layer is implantable against tissue by staples deployed from the cartridge body and deformed by an anvil. The cartridge and the layer comprise co-operating features which reduce relative movement between the cartridge and the layer. Such co-operating features can also releasably retain the layer to the cartridge body. In addition to or in lieu of the above, the anvil and the layer comprise co-operating features which reduce relative movement between the anvil and the layer. Such co-operating features can also releasably retain the layer to the anvil. In certain instances, the layer can be positioned against the anvil, but releasably attached to the cartridge. The layer can comprise buttress material and/or a tissue thickness compensator, for example.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 15/847,759, entitledSTAPLE CARTRIDGE COMPRISING A RELEASABLE ADJUNCT MATERIAL, filed Dec.19, 2017, now U.S. Patent Application Publication No. 2018/0296215,which is a continuation application claiming priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 14/535,081, entitled STAPLECARTRIDGE COMPRISING A RELEASABLE ADJUNCT MATERIAL, filed Nov. 6, 2014,which issued on Dec. 19, 2017 as U.S. Pat. No. 9,844,376, the entiredisclosures of which are incorporated by reference herein.

BACKGROUND

The present invention relates to stapling instruments and, in variousembodiments, to a surgical stapling instrument for producing one or morerows of staples.

A stapling instrument can include a pair of cooperating elongate jawmembers, wherein each jaw member can be adapted to be inserted into apatient and positioned relative to tissue that is to be stapled and/orincised. In various embodiments, one of the jaw members can support astaple cartridge with at least two laterally spaced rows of staplescontained therein, and the other jaw member can support an anvil withstaple-forming pockets aligned with the rows of staples in the staplecartridge. Generally, the stapling instrument can further include apusher bar and a knife blade which are slidable relative to the jawmembers to sequentially eject the staples from the staple cartridge viacamming surfaces on the pusher bar and/or camming surfaces on a wedgesled that is pushed by the pusher bar. In at least one embodiment, thecamming surfaces can be configured to activate a plurality of stapledrivers carried by the cartridge and associated with the staples inorder to push the staples against the anvil and form laterally spacedrows of deformed staples in the tissue gripped between the jaw members.In at least one embodiment, the knife blade can trail the cammingsurfaces and cut the tissue along a line between the staple rows.Examples of such stapling instruments are disclosed in U.S. Pat. No.7,794,475, entitled SURGICAL STAPLES HAVING COMPRESSIBLE OR CRUSHABLEMEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FORDEPLOYING THE SAME, the entire disclosure of which is herebyincorporated by reference herein.

The foregoing discussion is intended only to illustrate various aspectsof the related art in the field of the invention at the time, and shouldnot be taken as a disavowal of claim scope.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of the embodiments described herein are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation, together withadvantages thereof, may be understood in accordance with the followingdescription taken in conjunction with the accompanying drawings asfollows:

FIG. 1 is a perspective view of a staple cartridge in accordance with atleast one embodiment comprising a cartridge body and a layer releasablyattached to the cartridge body by retractable retaining members;

FIG. 2 is a partial cross-sectional view of the staple cartridge of FIG.1 illustrating the retaining members in an extended position;

FIG. 3 is a partial cross-sectional view of the staple cartridge of FIG.1 illustrating the retaining members in a retracted position;

FIG. 4 is a partial perspective view of a staple cartridge in accordancewith at least one embodiment comprising a cartridge body and a layerreleasably attached to the cartridge body by a liftable retainingmember;

FIG. 5 is a partial cross-sectional view of the staple cartridge of FIG.4 illustrating the retaining member in a gripping position;

FIG. 6 is a partial cross-sectional view of the staple cartridge of FIG.4 illustrating the retaining member in a lifted position;

FIG. 7 is a partial perspective view of an end effector assemblyincluding a staple cartridge comprising a cartridge body and a cartridgelayer releasably attached to the cartridge body and, in addition, ananvil layer releasably attached to the cartridge body;

FIG. 8 is a cross-sectional elevational view of the end effectorassembly of FIG. 7;

FIG. 9 is a partial cross-sectional plan view of the end effectorassembly of FIG. 7 illustrating the proximal ends of the cartridge layerand the anvil layer releasably attached to the cartridge body; and

FIG. 10 is a partial cross-sectional plan view of the end effectorassembly of FIG. 7 illustrating the proximal ends of the cartridge layerand the anvil layer released from the cartridge body.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate various embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

The Applicant of the present application also owns the U.S. PatentApplications identified below which are each herein incorporated byreference in their respective entirety:

U.S. patent application Ser. No. 12/894,311, entitled SURGICALINSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS; now U.S. Pat. No.8,763,877;

U.S. patent application Ser. No. 12/894,340, entitled SURGICAL STAPLECARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICALSTAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS; now U.S. Pat.No. 8,899,463;

U.S. patent application Ser. No. 12/894,327, entitled JAW CLOSUREARRANGEMENTS FOR SURGICAL INSTRUMENTS; now U.S. Pat. No. 8,978,956;

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U.S. patent application Ser. No. 12/894,338, entitled IMPLANTABLEFASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT; now U.S. Pat. No.8,864,007;

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U.S. patent application Ser. No. 12/894,312, entitled IMPLANTABLEFASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS; now U.S. Pat. No.8,925,782;

U.S. patent application Ser. No. 12/894,377, entitled SELECTIVELYORIENTABLE IMPLANTABLE FASTENER CARTRIDGE; now U.S. Pat. No. 8,393,514;

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U.S. patent application Ser. No. 12/894,360, entitled SURGICAL STAPLINGINSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM; now U.S. Pat. No.9,113,862;

U.S. patent application Ser. No. 12/894,322, entitled SURGICAL STAPLINGINSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS; now U.S.Pat. No. 8,740,034;

U.S. patent application Ser. No. 12/894,350, entitled SURGICAL STAPLECARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES; now U.S. PatentApplication Publication No. 2012/0080478;

U.S. patent application Ser. No. 12/894,383, entitled IMPLANTABLEFASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS; now U.S. Pat. No.8,752,699;

U.S. patent application Ser. No. 12/894,389, entitled COMPRESSIBLEFASTENER CARTRIDGE; now U.S. Pat. No. 8,740,037;

U.S. patent application Ser. No. 12/894,345, entitled FASTENERSSUPPORTED BY A FASTENER CARTRIDGE SUPPORT; now U.S. Pat. No. 8,783,542;

U.S. patent application Ser. No. 12/894,306, entitled COLLAPSIBLEFASTENER CARTRIDGE; now U.S. Pat. No. 9,044,227;

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U.S. patent application Ser. No. 13/097,861, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING PORTIONS HAVING DIFFERENT PROPERTIES; now U.S.Pat. No. 9,113,865;

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U.S. patent application Ser. No. 13/097,873, entitled STAPLE CARTRIDGECOMPRISING A RELEASABLE PORTION; now U.S. Pat. No. 8,740,038;

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U.S. patent application Ser. No. 13/097,924, entitled STAPLE CARTRIDGECOMPRISING A TISSUE THICKNESS COMPENSATOR; now U.S. Pat. No. 9,168,038;

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U.S. patent application Ser. No. 13/241,637, entitled SURGICALINSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATIONMOTIONS; now U.S. Pat. No. 8,789,741;

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U.S. application Ser. No. 13/763,094, entitled LAYER COMPRISINGDEPLOYABLE ATTACHMENT MEMBERS; now U.S. Patent Application PublicationNo. 2013/0256377;

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U.S. application Ser. No. 13/763,065, entitled FASTENER CARTRIDGECOMPRISING A RELEASABLY ATTACHED TISSUE THICKNESS COMPENSATOR; now U.S.Pat. No. 9,566,061;

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U.S. application Ser. No. 13/851,684, entitled FASTENER CARTRIDGECOMPRISING A TISSUE THICKNESS COMPENSATOR AND A GAP SETTING ELEMENT; nowU.S. Patent Application Publication No. 2014/0291380;

U.S. patent application Ser. No. 14/187,383, entitled IMPLANTABLE LAYERSAND METHODS FOR ALTERING IMPLANTABLE LAYERS FOR USE WITH SURGICALFASTENING INSTRUMENTS, now U.S. Patent Application Publication No.2015/0238185;

U.S. patent application Ser. No. 14/187,386, entitled IMPLANTABLE LAYERSAND METHODS FOR ALTERING ONE OR MORE PROPERTIES OF IMPLANTABLE LAYERSFOR USE WITH FASTENING INSTRUMENTS, now U.S. Patent ApplicationPublication No. 2015/0239180;

U.S. patent application Ser. No. 14/187,390, entitled IMPLANTABLE LAYERSAND METHODS FOR MODIFYING THE SHAPE OF THE IMPLANTABLE LAYERS FOR USEWITH A SURGICAL FASTENING INSTRUMENT, now U.S. Patent ApplicationPublication No. 2015/0238188;

U.S. patent application Ser. No. 14/187,389, entitled IMPLANTABLE LAYERASSEMBLIES, now U.S. Pat. No. 9,757,124;

U.S. patent application Ser. No. 14/187,385, entitled IMPLANTABLE LAYERSCOMPRISING A PRESSED REGION, now U.S. Pat. No. 9,693,777;

U.S. patent application Ser. No. 14/187,384, entitled FASTENING SYSTEMCOMPRISING A FIRING MEMBER LOCKOUT, now U.S. Pat. No. 9,775,608; and

U.S. patent application Ser. No. 14/516,277, entitled STAPLE CARTRIDGECOMPRISING AN ADJUNCT MATERIAL, now U.S. Pat. No. 9,924,944.

Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. It will be understood by those skilled in theart, however, that the embodiments may be practiced without suchspecific details. In other instances, well-known operations, components,and elements have not been described in detail so as not to obscure theembodiments described in the specification. Those of ordinary skill inthe art will understand that the embodiments described and illustratedherein are non-limiting examples, and thus it can be appreciated thatthe specific structural and functional details disclosed herein may berepresentative and illustrative. Variations and changes thereto may bemade without departing from the scope of the claims.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a surgicalsystem, device, or apparatus that “comprises,” “has,” “includes” or“contains” one or more elements possesses those one or more elements,but is not limited to possessing only those one or more elements.Likewise, an element of a system, device, or apparatus that “comprises,”“has,” “includes” or “contains” one or more features possesses those oneor more features, but is not limited to possessing only those one ormore features.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical”, “horizontal”, “up”, and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, theperson of ordinary skill in the art will readily appreciate that thevarious methods and devices disclosed herein can be used in numeroussurgical procedures and applications including, for example, inconnection with open surgical procedures. As the present DetailedDescription proceeds, those of ordinary skill in the art will furtherappreciate that the various instruments disclosed herein can be insertedinto a body in any way, such as through a natural orifice, through anincision or puncture hole formed in tissue, etc. The working portions orend effector portions of the instruments can be inserted directly into apatient's body or can be inserted through an access device that has aworking channel through which the end effector and elongated shaft of asurgical instrument can be advanced.

Many of the above-listed patent applications disclose various layerswhich are used in connection with a staple cartridge. When staples aredeployed from the staple cartridge, the staples can capture at least onelayer and implant the layer, or layers, against the tissue. Providedbelow is a brief description of a surgical stapling system. The staplecartridges and the layers disclosed herein can be used with thissurgical stapling system and/or any suitable stapling system.

A surgical stapling system can comprise a shaft and an end effectorextending from the shaft. The end effector comprises a first jaw and asecond jaw. The first jaw comprises a staple cartridge. The staplecartridge is insertable into and removable from the first jaw; however,other embodiments are envisioned in which a staple cartridge is notremovable from, or at least readily replaceable from, the first jaw. Thesecond jaw comprises an anvil configured to deform staples ejected fromthe staple cartridge. The second jaw is pivotable relative to the firstjaw about a closure axis; however, other embodiments are envisioned inwhich first jaw is pivotable relative to the second jaw. The surgicalstapling system further comprises an articulation joint configured topermit the end effector to be rotated, or articulated, relative to theshaft. The end effector is rotatable about an articulation axisextending through the articulation joint. Other embodiments areenvisioned which do not include an articulation joint.

The staple cartridge comprises a cartridge body. The cartridge bodyincludes a proximal end, a distal end, and a deck extending between theproximal end and the distal end. In use, the staple cartridge ispositioned on a first side of the tissue to be stapled and the anvil ispositioned on a second side of the tissue. The anvil is moved toward thestaple cartridge to compress and clamp the tissue against the deck.Thereafter, staples removably stored in the cartridge body can bedeployed into the tissue. The cartridge body includes staple cavitiesdefined therein wherein staples are removably stored in the staplecavities. The staple cavities are arranged in six longitudinal rows.Three rows of staple cavities are positioned on a first side of alongitudinal slot and three rows of staple cavities are positioned on asecond side of the longitudinal slot. Other arrangements of staplecavities and staples may be possible.

The staples are supported by staple drivers in the cartridge body. Thedrivers are movable between a first, or unfired position, and a second,or fired, position to eject the staples from the staple cavities. Thedrivers are retained in the cartridge body by a retainer which extendsaround the bottom of the cartridge body and includes resilient membersconfigured to grip the cartridge body and hold the retainer to thecartridge body. The drivers are movable between their unfired positionsand their fired positions by a sled. The sled is movable between aproximal position adjacent the proximal end and a distal positionadjacent the distal end. The sled comprises a plurality of rampedsurfaces configured to slide under the drivers and lift the drivers, andthe staples supported thereon, toward the anvil.

Further to the above, the sled is moved distally by a firing member. Thefiring member is configured to contact the sled and push the sled towardthe distal end. The longitudinal slot defined in the cartridge body isconfigured to receive the firing member. The anvil also includes a slotconfigured to receive the firing member. The firing member furthercomprises a first cam which engages the first jaw and a second cam whichengages the second jaw. As the firing member is advanced distally, thefirst cam and the second cam can control the distance, or tissue gap,between the deck of the staple cartridge and the anvil. The firingmember also comprises a knife configured to incise the tissue capturedintermediate the staple cartridge and the anvil. It is desirable for theknife to be positioned at least partially proximal to the rampedsurfaces such that the staples are ejected ahead of the knife.

An end effector assembly 1000 is depicted in FIGS. 1-3. The end effectorassembly 1000 comprises a first jaw 1001 and a second jaw 1002. Thefirst jaw 1001 comprises a staple cartridge 1005. The staple cartridge1005 is readily removable from the first jaw 1001 and can be replacedwith another staple cartridge. Other embodiments are envisioned in whichthe staple cartridge 1005 is not readily removable from the first jaw1001. The staple cartridge 1005 comprises a cartridge body 1010 and animplantable layer 1020. The cartridge body 1010 comprises a proximal end1011, a distal end 1012, and a deck 1013 configured to support tissue.As discussed in greater detail further below, the layer 1020 isreleasably retained to the deck 1013. The cartridge body 1010 furthercomprises a longitudinal slot 1014 and a plurality of staple cavities1015 defined in the deck 1013. The staple cartridge 1005 furthercomprises staples 1040, and/or any other suitable fastener, removablystored in the staple cavities 1015 and staple drivers 1050 configured tolift the staples 1040 toward the deck 1013. The drivers 1050, and thestaples 1040 supported thereon, are movable between an unfired position(FIG. 2) and a fired position (FIG. 3) by a firing member, such as sled1060, for example. The sled 1060 can be pushed forward by a firing bar1061 (FIG. 8) or, alternatively, the sled 1060 can be integrally formedwith a firing bar. In either event, the sled 1060 comprises rampedsurfaces 1063 (FIG. 3) configured to slide under the staple drivers 1050and lift the staple drivers 1050 upwardly as the sled 1060 is advancedfrom a proximal position (FIGS. 8 and 9) toward a distal position (FIG.3).

The second jaw 1002 comprises an anvil 1030 configured to deform thestaples 1040. The second jaw 1002 is rotatable relative to the first jaw1001 and, thus, the anvil 1030 is rotatable relative to the staplecartridge 1005; however, certain embodiments are envisioned in which thestaple cartridge 1005 is rotatable relative to the anvil 1030. The sled1060 and/or the firing bar 1061 can include a first cam 1067 (FIG. 8)configured to engage the first jaw 1001 and a second cam 1069 (FIG. 8)configured to engage the second jaw 1002 as the sled 1060 and the firingbar 1061 are advanced distally. The first cam 1067 and the second cam1069 can co-operate to position the anvil 1030 relative to the staplecartridge 1005 and define a tissue gap therebetween. The first jaw 1001comprises a first cam slot 1007 defined therein configured to receivethe first cam 1067 and the second jaw 1002 comprises a second cam slot1009 defined therein configured to receive the second cam 1069. The sled1060 and/or the firing bar 1061 can comprise a cutting surface, such asa knife edge 1062 (FIG. 8), for example, configured to incise the tissueand the layer 1020 captured between the anvil 1030 and the staplecartridge 1005.

Referring again to FIGS. 1-3, the layer 1020 is releasably retained tothe cartridge body 1010. The layer 1020 comprises a proximal end 1021positioned over the proximal end 1011 of the cartridge body 1010 and adistal end 1022 positioned over the distal end 1012. The staplecartridge 1005 further comprises a layer retainer 1070 which is movablebetween a first position in which the layer retainer 1070 releasablyholds the distal end 1022 of the layer 1020 to the distal end 1012 ofthe cartridge body 1010 (FIG. 2) and a second position in which thedistal end 1022 of the layer 1020 is released from the distal end 1012(FIG. 3). The staple cartridge 1005 actually comprises two layerretainers 1070—a first layer retainer 1070 positioned on a first side ofthe longitudinal slot 1014 and a second layer retainer 1070 positionedon a second side of the longitudinal slot 1014; however, a staplecartridge can comprise any suitable number of layer retainers. The firstlayer retainer 1070 is aligned with a first row of staple cavities 1015and/or staple drivers 1050 in the cartridge body 1010 and the secondretainer 1070 is aligned with a second row of staple cavities 1015and/or staple drivers 1050. Each layer retainer 1070 comprises at leastone pin 1073 which is received within a pin aperture 1023 defined in thelayer 1020 when the layer retainer 1070 is in its first position (FIG.2). In various instances, the pin 1073 and the pin aperture 1023 can besized and configured such that there is an interference fit therebetweenwhich can hold the distal end 1022 of the layer 1020 to the distal end1012 of the cartridge body 1010. When the layer retainer 1070 is movedinto its second position (FIG. 3), the pin 1073 is removed, or at leastsubstantially removed, from the pin aperture 1023 and, as a result, thelayer 1020, or at least the distal end 1022 of the layer 1020, may nolonger be connected to the cartridge body 1010, as discussed in greaterdetail further below.

Each layer retainer 1070 is movable from its first position—in which itis engaged with the layer 1020—to its second position—in which it isdisengaged from the layer 1020—by a staple driver 1050. The stapledrivers 1050 are arranged in a proximal-to-distal manner between theproximal end 1011 and the distal end 1012 of the cartridge body 1010wherein the distal-most staple drivers, i.e., staple drivers 1050 d,defeat the layer retainers 1070 when the staple drivers 1050 d arelifted toward the deck 1013 by the sled 1060. Each distal staple driver1050 d comprises an actuator 1051 extending distally therefrom which isconfigured to contact a switch arm 1071 extending proximally from thelayer retainer 1070 when the staple driver 1050 d is moved between itsunfired position (FIG. 2) and its fired position (FIG. 3). The switcharm 1071 extends from a fulcrum 1078 of the layer retainer 1070 whereinthe fulcrum 1078 is positioned, or positionable, against a pivot surface1018 defined in the cartridge body 1010 and is configured to permit thelayer retainer 1070 to rotate between its first position (FIG. 2) andits second position (FIG. 3) when the switch arm 1071 is driven upwardlyby the staple driver 1050 d. Although the layer retainer 1070 may rotatebetween its first position and its second position, the pin 1073 of thelayer retainer 1070 can be constrained such that it translates along alongitudinal path. In at least one instance, the cartridge body 1010further comprises a pin slot 1074 configured to closely receive the pin1073 which can limit the movement of the pin 1073 to motion along avertical axis, for example. The distal driver 1050 d can rotate theswitch arm 1071 upwardly until the switch arm 1071 abuts the pivotsurface 1078. At such point, the distal driver 1050 d is at itsfully-fired position.

As discussed above, the layer retainer 1070 is movable between a firstposition in which it holds the layer 1020 to the cartridge body 1010 anda second position in which the layer 1020 is released from the cartridgebody 1010. When the layer retainer 1070 is in its first position, thepin 1073 extends above the deck 1013 of the cartridge body 1010. Whenthe layer retainer 1070 is moved into its second position, the pin 1073is lowered relative to the deck 1013 and is positioned flush with orbelow the deck 1013. In such circumstances, the pin 1073 can becompletely removed from the pin aperture 1023 defined in the layer 1020.Other embodiments are envisioned in which the pin 1073 extends above thedeck 1013 when the layer retainer 1070 is in its second position. Insuch a position, the pin 1073 may or may not be partially positionedwithin the pin aperture 1023 defined in the layer 1020. In the eventthat the pin 1073 is still partially positioned within the pin aperture1020 when the layer retainer 1070 is in its second position, the layer1020 may still slip off of the pins 1073 and allow the layer 1020 to bedetached from the cartridge body 1010. In various instances, a clearancefit may exist between the pins 1073 and the layer apertures 1023.

The staple cartridge 1005 can include a biasing member, such as aspring, for example, configured to bias the layer retainers 1070 intotheir first positions. In some instances, the staple cartridge 1005 cancomprise a first biasing member which biases the first layer retainer1070 into its first portion and a second biasing member which biases thesecond layer retainer 1070 into its first position. When the distaldrivers 1050 d push the layer retainers 1070 into their secondpositions, the distal drivers 1050 d can overcome the biasing forcesapplied by the biasing members.

The layer retainers 1070 hold the layer 1020 to the cartridge body 1010before the sled 1060 and the firing bar 1061 are advanced distallyduring a firing stroke. This arrangement can be helpful to hold thelayer 1020 in position while the staple cartridge 1005 is positionedrelative to the tissue that is to be stapled. Once the staple cartridge1005 has been suitably positioned relative to the tissue, the anvil 1030can be moved into a closed position to clamp the tissue against thelayer 1020. At such point, the sled 1060 and the firing bar 1061 can beadvanced distally through their firing stroke. The layer retainer 1070can hold the layer 1020 to the cartridge body 1010 during the entiretyof the firing stroke or, alternatively, during a portion of the firingstroke. In various instances, the layer retainer 1070 may not be releasethe layer 1020 from the cartridge body 1010 until or after all of thestaples 1040 have been fully fired. In some instances, the layerretainer 1070 can release the layer 1020 prior to, or immediately priorto, the completion of the firing stroke In any event, the layer retainer1070 can prevent or inhibit the layer 1020 from being pushed distally bythe knife edge 1062 when the knife edge 1062 is moved distally totransect the layer 1020. In the event that the sled 1060 and the firingbar 1061 are not advanced through their full firing stroke, the layerretainers 1070 may not be defeated by the distal drivers 1050 d and, assuch, the layer retainers 1070 may continue to hold the layer 1020 tothe cartridge body 1010. The pins 1073 of the layer retainers 1070 andthe pin apertures 1023 of the layer 1020 can be sized and configured toprovide a certain amount of retention force therebetween which canresist the movement of the layer 1020 prior to and during the firingstroke but permit the layer 1020 to be pulled away from the cartridgebody 1010 in the event that the firing stroke is not completed.

Turning now to FIGS. 4-6, an end effector assembly 1100 comprises afirst jaw 1001 and a second jaw 1002. The first jaw 1001 comprises astaple cartridge 1105. The staple cartridge 1105 is readily removablefrom the first jaw 1001 and can be replaced with another staplecartridge. Other embodiments are envisioned in which the staplecartridge 1105 is not readily removable from the first jaw 1001. Thestaple cartridge 1105 comprises a cartridge body 1110 and an implantablelayer 1120. The cartridge body 1110 comprises a proximal end 1111 (FIGS.9 and 10), a distal end 1112, and a deck 1113 configured to supporttissue. As discussed in greater detail further below, the layer 1120 isreleasably retained to the deck 1113. The cartridge body 1110 furthercomprises a longitudinal slot 1114 and a plurality of staple cavities1015 defined in the deck 1113. The staple cartridge 1105 furthercomprises staples 1040, and/or any other suitable fastener, removablystored in the staple cavities 1015 and staple drivers 1150 configured tolift the staples 1040 toward the deck 1113. The drivers 1150, and thestaples 1040 supported thereon, are movable between an unfired position(FIG. 8) and a fired position (FIGS. 5 and 6) by a firing member, suchas sled 1060, for example. The sled 1060 can be pushed forward by afiring bar 1061 (FIG. 8) or, alternatively, the sled 1060 can beintegrally formed with a firing bar. In either event, the sled 1060comprises ramped surfaces 1063 (FIGS. 5 and 6) configured to slide underthe staple drivers 1150 and lift the staple drivers 1150 upwardly as thesled 1060 is advanced from a proximal position (FIGS. 8 and 9) toward adistal position (FIG. 3).

The second jaw 1002 comprises an anvil 1030 configured to deform thestaples 1040. The second jaw 1002 is rotatable relative to the first jaw1001 and, thus, the anvil 1030 is rotatable relative to the staplecartridge 1105; however, certain embodiments are envisioned in which thestaple cartridge 1105 is rotatable relative to the anvil 1030. The sled1060 and/or the firing bar 1061 can include a first cam 1067 (FIG. 8)configured to engage the first jaw 1001 and a second cam 1069 (FIG. 8)configured to engage the second jaw 1002 as the sled 1060 and the firingbar 1061 are advanced distally. The first cam 1067 and the second cam1069 can co-operate to position the anvil 1030 relative to the staplecartridge 1105 and define a tissue gap therebetween. The first jaw 1001comprises a first cam slot 1007 (FIGS. 2 and 3) defined thereinconfigured to receive the first cam 1067 and the second jaw 1002comprises a second cam slot 1009 (FIGS. 2 and 3) defined thereinconfigured to receive the second cam 1069. The sled 1060 and/or thefiring bar 1061 can comprise a cutting surface, such as a knife edge1062 (FIG. 8), for example, configured to incise the tissue and thelayer 1120 captured between the anvil 1030 and the staple cartridge1105.

Referring again to FIGS. 4-6, the layer 1120 is releasably retained tothe cartridge body 1110. The layer 1120 comprises a proximal endpositioned over the proximal end 1111 (FIGS. 8-10) of the cartridge body1110 and a distal end 1122 positioned over the distal end 1112. Thestaple cartridge 1105 further comprises a layer retainer 1170 which ismovable between a first position in which the layer retainer 1170releasably holds the distal end 1122 of the layer 1120 to the distal end1112 of the cartridge body 1110 (FIGS. 4 and 5) and a second position inwhich the distal end 1122 of the layer 1120 is released from the distalend 1112 (FIG. 6). The layer retainer 1170 is aligned with thelongitudinal slot 1114 defined in the cartridge body 1110. The layerretainer 1170 comprises a clip 1173 which is received within a clip slot1123 defined in the cartridge body 1110 when the layer retainer 1170 isin its first position (FIG. 5). In various instances, the clip 1173 andthe clip slot 1123 can be sized and configured such that the distal end1122 of the layer 1120 is wedged therebetween and, as a result, thelayer 1120 is releasably held to the distal end 1112 of the cartridgebody 1110. When the layer retainer 1170 is moved into its secondposition (FIG. 6), the clip 1173 is removed, or at least substantiallyremoved, from the clip slot 1123 and, as a result, the layer 1120, or atleast the distal end 1122 of the layer 1120, may no longer be connectedto the cartridge body 1110, as discussed in greater detail furtherbelow.

The layer retainer 1170 is movable from its first position—in which itis engaged with the layer 1120—to its second position—in which it isdisengaged from the layer 1120—by the sled 1060. The sled 1060 comprisesa central portion 1064 which translates within the longitudinal slot1114 and includes a cam surface configured to engage the layer retainer1170 and lift the layer retainer 1170 from its first position toward itssecond position. The layer retainer 1170 includes a switch arm 1171extending proximally which is contacted by the central portion 1064 andpushed upwardly. The cartridge body 1110 comprises a guide slot 1172defined therein which is configured to closely receive the layerretainer 1170 and guide the layer retainer 1170 along a longitudinalpath such that, when the switch arm 1171 is pushed upwardly by the sled1060, the clip 1173 of the layer retainer 1170 is pushed upwardly aswell. In various alternative embodiments, the layer retainer 1170 can bepushed upwardly by the ramp surfaces 1063 defined on the sled 1060.

As discussed above, the layer retainer 1170 is movable between a firstposition in which it holds the layer 1120 to the cartridge body 1110 anda second position in which the layer 1120 is released from the cartridgebody 1110. When the layer retainer 1170 is in its first position, a cliplip 1174 of the clip 1173 extends into the clip slot 1123 defined in thecartridge body 1110. In such a position, the layer 1120 is trappedbetween the clip lip 1174 and a clip slot lip 1124. In such a position,the clip 1173 may extend above, be recessed below, or be flush with thedeck 1113 of the cartridge body 1110. When the layer retainer 1170 ismoved into its second position, the clip lip 1174 is lifted relative toand/or above the deck 1113 and away from the clip slot lip 1124. In sucha position, the layer 1120 can readily slide out between the clip lip1174 and the clip slot lip 1124. In various instances, the distal end1121 of the layer 1120 may comprise a continuous material withoutapertures defined therein, for example. Such an arrangement may reducepotential irritation to the tissue.

As discussed above, the layer retainer 1170 holds the layer 1120 to thecartridge body 1110 before the sled 1060 and the firing bar 1061 areadvanced distally during a firing stroke. This arrangement can behelpful to hold the layer 1120 in position while the staple cartridge1105 is positioned relative to the tissue that is to be stapled. Oncethe staple cartridge 1105 has been suitably positioned relative to thetissue, the anvil 1030 can be moved into a closed position to clamp thetissue against the layer 1120. At such point, the sled 1060 and thefiring bar 1061 can be advanced distally through their firing stroke.The layer retainer 1170 can hold the layer 1120 to the cartridge body1110 during the entirety of the firing stroke or, alternatively, duringa portion of the firing stroke. In various instances, the layer retainer1170 may not be release the layer 1120 from the cartridge body 1110until or after all of the staples 1040 have been fully fired. In someinstances, the layer retainer 1170 can release the layer 1120 prior to,or immediately prior to, the completion of the firing stroke In anyevent, the layer retainer 1170 can prevent or inhibit the layer 1120from being pushed distally by the knife edge 1062 when the knife edge1062 is moved distally to transect the layer 1120. In the event that thesled 1060 and the firing bar 1061 are not advanced through their fullfiring stroke, the layer retainer 1170 may not be defeated by the sled1060 and, as such, the layer retainer 1170 may continue to hold thelayer 1120 to the cartridge body 1110. The clip 1173 of the layerretainer 1170 and the clip slot 1123 of the layer 1120 can be sized andconfigured to provide a certain amount of retention force therebetweenwhich can resist the movement of the layer 1120 prior to and during thefiring stroke but permit the layer 1120 to be pulled away from thecartridge body 1110 in the event that the firing stroke is notcompleted.

As discussed above, a staple cartridge can include a layer retainerpositioned at the distal end thereof to releasably hold the layer to thestaple cartridge. In addition to or in lieu of the distal layerretainer, a staple cartridge can include a layer retainer positioned atthe proximal end thereof. Turning now to FIGS. 7-10, an end effectorassembly 1200 comprises a first jaw 1001 and a second jaw 1002. Thefirst jaw 1001 comprises a staple cartridge 1205. The staple cartridge1205 is readily removable from the first jaw 1001 and can be replacedwith another staple cartridge. Other embodiments are envisioned in whichthe staple cartridge 1205 is not readily removable from the first jaw1001. The staple cartridge 1205 comprises a cartridge body 1110 and animplantable layer 1220. As discussed in greater detail further below,the layer 1220 is releasably retained to the deck 1113 of the cartridgebody 1110.

The second jaw 1002 is rotatable relative to the first jaw 1001 and,thus, the anvil 1030 is rotatable relative to the staple cartridge 1205;however, certain embodiments are envisioned in which the staplecartridge 1205 is rotatable relative to the anvil 1030. The sled 1060and/or the firing bar 1061 can include a first cam 1067 (FIG. 8)configured to engage the first jaw 1001 and a second cam 1069 (FIG. 8)configured to engage the second jaw 1002 as the sled 1060 and the firingbar 1061 are advanced distally. The first cam 1067 and the second cam1069 can co-operate to position the anvil 1030 relative to the staplecartridge 1205 and define a tissue gap therebetween. The sled 1060and/or the firing bar 1061 can comprise a cutting surface, such as aknife edge 1062 (FIG. 8), for example, configured to incise the tissueand the layer 1220 captured between the anvil 1030 and the staplecartridge 1205.

Referring again to FIGS. 7-10, the layer 1220 is releasably retained tothe cartridge body 1110. The layer 1220 comprises a proximal end 1221positioned over the proximal end 1111 of the cartridge body 1110 and adistal end 1222 positioned over the distal end 1112. The proximal end1221 of the layer 1220 comprises a layer retainer 1225 which isreleasably held to the staple cartridge 1205. The layer retainer 1225comprises a tail which is wedged or captured between the sled 1060 andthe cartridge body 1110 when the cartridge body 1060 is in its proximal,unfired position, as illustrated in FIGS. 7-9. Referring primarily toFIG. 9, the tail of the layer retainer 1225 is positioned intermediatethe central portion 1064 of the sled 1060 and a first longitudinalsidewall 1114 a of the slot 1114 and, owing to an interference fittherebetween, the proximal end 1221 of the layer 1220 is releasably heldto the proximal end 1111 of the cartridge body 1110. The first sidewall1114 a comprises a first recess 1226 defined therein configured toreceive an enlarged tab 1227 defined at the end of the layer retainertail 1225. The enlarged tab 1227 can be sized and configured such thatit is prevented, or at least inhibited, from being pulled of the firstrecess 1226 prior to the sled 1060 being advanced distally. In additionto or in lieu of the above, the sled 1060 can include a dimple extendingtherefrom configured to pin the layer retainer 1225 against the firstsidewall 1114 a of the longitudinal slot 1114. Also, in addition to orin lieu of the above, the first sidewall 1114 a of the longitudinal slot1114 can include a dimple extending therefrom configured to pin thelayer retainer 1225 against the sled 1060. In any event, referringprimarily to FIGS. 7 and 9, the central portion 1064 of the sled 1060includes a recess 1065 defined therein through which the layer retainer1225 can extend when the sled 1060 is in its proximal, unfired position.

When the sled 1060 is advanced distally from its proximal position,referring primarily to FIG. 10, the layer retainer 1225 is no longertrapped intermediate the sled 1060 and the first sidewall 1114 a and, asa result, the enlarged tab 1227 can readily slide out of the firstrecess 1226 and the longitudinal slot 1114. In the embodiments where theproximal layer retainer 1225 is the only layer retainer holding thelayer 1220 to the cartridge body, the release of the proximal layerretainer 1225 can release the layer 1220 from the cartridge body 1110.In such instances, the initiation of the firing stroke of the sled 1060and the firing bar 1061 can release the layer 1220 from the cartridgebody 1110. In the embodiments comprising a distal layer retainer inaddition to the proximal layer retainer, the distal end 1222 of thelayer 1220 is still releasably retained to the cartridge body 1110 eventhough the proximal end 1221 of the layer 1220 has been released.

As discussed above, an end effector assembly can include an implantablelayer releasably attached to a staple cartridge. In addition to or inlieu of a staple cartridge layer, an end effector assembly can includean implantable layer releasably attached to an anvil of the end effectorassembly. Referring again to FIGS. 7-10, the end effector assembly 1200comprises an anvil layer 1320 releasably attached thereto. The anvillayer 1320 comprises a proximal end 1321 positioned adjacent a proximalend of the anvil 1030 and a distal end 1322 positioned adjacent a distalend of the anvil 1030. The proximal end 1321 of the layer 1320 comprisesa layer retainer 1325 which is releasably held to the staple cartridge1205. The layer retainer 1325 comprises a tail which is wedged orcaptured between the sled 1060 and the cartridge body 1110 when thecartridge body 1060 is in its proximal, unfired position, as illustratedin FIGS. 7-9. Referring primarily to FIG. 9, the tail of the layerretainer 1325 is positioned intermediate the central portion 1064 of thesled 1060 and a second longitudinal sidewall 1114 b of the slot 1114and, owing to an interference fit therebetween, the proximal end 1321 ofthe layer 1320 is releasably held to the proximal end 1111 of thecartridge body 1110. The second sidewall 1114 b comprises a secondrecess 1326 defined therein configured to receive an enlarged tab 1327defined at the end of the layer retainer tail 1325. The enlarged tab1327 can be sized and configured such that it is prevented, or at leastinhibited, from being pulled of the second recess 1326 prior to the sled1060 being advanced distally. In addition to or in lieu of the above,the sled 1060 can include a dimple extending therefrom configured to pinthe layer retainer 1325 against the second sidewall 1114 b of thelongitudinal slot 1114. Also, in addition to or in lieu of the above,the second sidewall 1114 b of the longitudinal slot 1114 can include adimple extending therefrom configured to pin the layer retainer 1325against the sled 1060. In any event, referring primarily to FIGS. 7 and9, the central portion 1064 of the sled 1060 includes a recess 1065defined therein through which the layer retainer 1325 can extend whenthe sled 1060 is in its proximal, unfired position.

When the sled 1060 is advanced distally from its proximal position,referring primarily to FIG. 10, the layer retainer 1325 is no longertrapped intermediate the sled 1060 and the second sidewall 1114 b and,as a result, the enlarged tab 1327 can readily slide out of the secondrecess 1326 and the longitudinal slot 1114. In the embodiments where theproximal layer retainer 1375 is the only layer retainer holding thelayer 1320 to the end effector 1200, the release of the proximal layerretainer 1325 can release the layer 1320 from the end effector 1200. Insuch instances, the initiation of the firing stroke of the sled 1060 andthe firing bar 1061 can release the layer 1320 from the end effector1200. In the embodiments comprising a distal layer retainer in additionto the proximal layer retainer, the distal end 1322 of the layer 1320 isstill releasably retained to the end effector 1200 even though theproximal end 1321 of the layer 1320 has been released. For instance, thedistal end 1322 of the layer 1320 comprises a distal layer retainer 1324which releasably holds the distal end 1322 to the distal end of theanvil 1030.

The distal layer retainer 1324 comprises a hook which extends into thesecond cam slot 1009 of the anvil 1030. The layer retainer 1324 holdsthe layer 1320 to the anvil 1030 before the sled 1060 and the firing bar1061 are advanced distally during a firing stroke. This arrangement canbe helpful to hold the layer 1320 in position while the anvil 1030 ispositioned relative to the tissue that is to be stapled. Once the anvil1030 has been suitably positioned relative to the tissue, the anvil 1030can be moved into a closed position to clamp the tissue against thestaple cartridge 1205, for example. At such point, the layer retainer1324 can hold the layer 1320 to the anvil 1030 during the entirety ofthe firing stroke or, alternatively, during a portion of the firingstroke. In either event, the anvil 1030 can be slid proximally away fromthe distal end 1322 of the at least partially implanted layer 1320 suchthat the distal layer retainer 1324 disengages from the second cam slot1009 of the anvil 1030.

In addition to or in lieu of releasably retaining a layer to a cartridgebody by way of a proximal layer retainer and/or a distal layer retainer,a layer can include one or more layer retainers releasably engaged witha longitudinal slot defined in the cartridge body, for example.Referring primarily to FIG. 8, the cartridge layer 1220 comprises alongitudinal series, or array, of tabs 1223 aligned with and releasablywedged within the longitudinal slot 1114. The series of tabs 1223extends between the proximal end 1221 and the distal end 1222 of thelayer 1220, although other configurations are contemplated which do notextend along the entire length of the layer 1220. Each tab 1223comprises a cantilever member, for example, which extends from a bodyportion of the layer 1220. The tabs 1223 can be integrally-formed withthe body portion of the layer 1220 and/or assembled to the body portion.In various instances, each tab 1223 can comprise at least one of aT-shaped configuration, an I-shaped configuration, and a V-shapedconfiguration, for example. In certain instances, the tabs 1223 can beformed by way of a laser-cutting process, for example. The tabs 1223 areengaged with the sidewalls 1114 a and 1114 b of the longitudinal slot1114 and are configured to prevent, or at least inhibit, relativemovement between the layer 1220 and the cartridge body 1110 prior toand/or during the firing stroke. During the firing stroke, the knife1062, for example, can transect the tabs 1223 as the firing bar 1061 isadvanced distally. When a tab 1223 is transected, the transected tab1223 may no longer be able to retain the layer 1220 to the cartridgebody 1110. As a result, the firing bar 1061 may progressively releasethe tabs 1223 from the longitudinal slot 1114. In certain embodiments,the sled 1060 and/or the firing bar 1061 can push the tabs 1223 out ofthe longitudinal slot 1114 as they are advanced distally. In eitherevent, all of the tabs 1223 can be released during a completed firingstroke while only a portion of the tabs 1223 may be released during apartial firing stroke. In the event that one or more tabs 1223 remainengaged with the cartridge body 1110 after the firing stroke has beencompleted, the tabs 1223 can be configured to slide out of the slot 1114when a sufficient force is applied thereto.

In addition to or in lieu of releasably retaining a layer to an anvil byway of a proximal layer retainer and/or a distal layer retainer, a layercan include one or more layer retainers releasably engaged with alongitudinal slot defined in the anvil, for example. Referring primarilyto FIGS. 7 and 8, the anvil layer 1320 comprises a longitudinal series,or array, of dimples 1323 aligned with and releasably wedged within thelongitudinal cam slot 1009. The series of dimples 1323 extends betweenthe proximal end 1321 and the distal end 1322 of the layer 1320,although other configurations are contemplated which do not extend alongthe entire length of the layer 1320. Each dimple 1323 comprises anelevated protrusion, for example, which extends from a body portion ofthe layer 1320. The dimples 1323 can be integrally-formed with the bodyportion of the layer 1320 and/or assembled to the body portion. Invarious instances, each dimple 1323 can comprise a cylindricalconfiguration, for example. In certain instances, the dimples 1323 canbe formed by way of a thermoforming and/or stretching process, forexample. The dimples 1323 are engaged with the sidewalls of the cam slot1009 and are configured to prevent, or at least inhibit, relativemovement between the layer 1320 and the anvil 1030 prior to and duringthe firing stroke. During the firing stroke, the knife 1062, forexample, can transect the dimples 1323 as the firing bar 1061 isadvanced distally. When a dimple 1323 is transected, the transecteddimple 1323 may no longer be able to retain the layer 1320 to the anvil1030. As a result, the firing bar 1061 may progressively release thedimples 1323 from the longitudinal slot 1009. In certain embodiments,the cam 1069 of the firing bar 1061 can push the dimples 1323 out of thecam slot 1009 as the firing bar 1061 is advanced distally. In eitherevent, all of the dimples 1323 can be released during a completed firingstroke while only a portion of the dimples 1323 may be released during apartial firing stroke. In the event that one or more dimples 1323 remainengaged with the anvil 1030 after the firing stroke has been completed,the dimples 1323 can be configured to slide out of the slot 1009 when asufficient force is applied thereto.

In various instances, all of the dimples 1323 can have the sameconfiguration. In other instances, certain dimples 1323 can havedifferent configurations. For instance, the proximal-most dimple 1323 pcan be larger than the dimples 1323 positioned distally with respect tothe dimple 1323 p and, as a result, the dimple 1323 p can provide agreater retention force to the anvil 1030 than the distal dimples 1323.Such an arrangement can allow the dimple 1323 with the greatestretention force to be released at the beginning of the firing stroke. Inaddition to or in lieu of the above, the distal-most dimple 1323 d canbe larger than dimples 1323 positioned proximally with respect to thedimple 1323 d and, as a result, the dimple 1323 d can provide a greaterretention force to the anvil 1030 than the proximal dimples 1323. Suchan arrangement can allow the dimple 1323 with the greatest retentionforce to be released at the end of the firing stroke. Moreover, such anarrangement can be more effective at inhibiting the movement of thedistal end 1322 of the layer 1320 which may experience larger shearforces when the end effector 1200 is positioned relative to the tissue.Various embodiments may include dimple 1323 p and dimple 1323 d. Alarger dimple 1323 can be taller, wider, and/or thicker than the otherdimples 1323, for example.

In various instances, the anvil layer 1320 can comprise a body portioncomprising a body thickness. The body thickness can be the thickness ofthe layer 1320 as measured from one side of the layer 1320, such as aside facing the anvil 1030, for example, and the other side of the layer1320, such as a side facing away from the anvil 1030, for example. Thethickness of each dimple 1323 can be measured in a similar manner, forinstance. In various embodiments, the dimple thickness can be the sameas the body thickness. In certain embodiments, the dimple thickness canbe thinner than the body thickness. Such an arrangement can result froma thermo-forming process, for example. Moreover, such an arrangement canpermit the thinner dimples 1323 to be more easily transected than thebody portion. In certain instances, further to the above, all of thedimples 1323 can have the same thickness while, in other instances,certain dimples 1323 can be thicker than others, such as theproximal-most dimple 1323 and/or the distal-most dimple 1323, forexample.

In various alternative embodiments, the cartridge layer 1200 cancomprise dimples 1323, for example. Also, in various alternativeembodiments, the anvil layer 1300 can comprise tabs 1223, for example.

In various instances, a layer of material can comprise buttress materialand/or a tissue thickness compensator, for example. The layer ofmaterial can be comprised of Gore SeamGuard material, SynovisPeri-Strips material, and/or polyurethane, for example. The entiredisclosure of U.S. patent application Ser. No. 13/763,095, entitledLAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES, filed on Feb. 28,2013, now U.S. Pat. No. 9,770,245, is incorporated by reference herein.The entire disclosures of U.S. patent application Ser. No. 13/531,619,entitled TISSUE STAPLER HAVING A THICKNESS COMPENSATOR COMPRISINGINCORPORATING A HEMOSTATIC AGENT, filed on Jun. 25, 2012, now U.S. Pat.No. 9,345,477, U.S. patent application Ser. No. 13/531,623, entitledTISSUE STAPLER HAVING A THICKNESS COMPENSATOR INCORPORATING AN OXYGENGENERATING AGENT, filed on Jun. 25, 2012, now U.S. Pat. No. 9,320,518,U.S. patent application Ser. No. 13/531,627, entitled TISSUE STAPLERHAVING A THICKNESS COMPENSATOR INCORPORATING AN ANTI-MICROBIAL AGENT,filed on Jun. 25, 2012, now U.S. Pat. No. 9,307,965, and U.S. patentapplication Ser. No. 13/531,630, entitled TISSUE STAPLER HAVING ATHICKNESS COMPENSATOR INCORPORATING AN ANTI-INFLAMMATORY AGENT, filed onJun. 25, 2012, now U.S. Pat. No. 9,314,246, are incorporated byreference herein. A layer can be comprised of a bioabsorbable materialand/or a non-bioabsorbable material. In some instances, a layer ofmaterial can be attached to the deck. In at least one instance, at leastone adhesive can be utilized to releasably adhere the layer to the deck.In some instances, the layer of material can be releasably attached tothe deck utilizing one or more sutures or straps, for example. Incertain instances, the layer can comprise a solid piece of material. Insome instances, the layer can include apertures defined therein.

Further to the above, the staples being deployed from a staple cartridgecan puncture the layer before entering into the tissue. The staples mayalso re-puncture the layer as they are being deformed by the anvil. Invarious instances, thicker or more puncture-resistant strips of polymercould be integrated into the layer, for example. For instance, suchstrips could be integrated into the tissue-contacting surface of thelayer. In at least one instance, each strip could be 0.003″ thick andcomprised of 90/10 PLA/PCL, for example. In certain instances, eachstrip could be 0.006″ thick 25/75 PGA/PCL, for example. The strips couldbe welded into the foam as part of a felting process, for example. Thedisclosure of U.S. patent application Ser. No. 14/187,383, entitledIMPLANTABLE LAYERS AND METHODS FOR ALTERING IMPLANTABLE LAYERS FOR USEWITH SURGICAL FASTENING INSTRUMENTS, now U.S. Pat. No. 9,839,422, isincorporated by reference in its entirety. The felting process couldserve another purpose which is to create a closed cell foam and/or acontinuous tissue contacting surface. In some instances, separate thinfilm strips could be welded into the tissue-contacting side of the foam.The various methods disclosed herein can create a composite absorbablematerial with features or zones aligned with the staples that havediffering properties for initial staple puncturing, forming, andre-piercing.

A layer, such as buttress material, for example, may be made from anybiocompatible material. Buttress material may be formed from a naturalmaterial and/or a synthetic material. Buttress material may bebioabsorbable and/or non-bioabsorbable. It should be understood that anycombination of natural, synthetic, bioabsorbable and non-bioabsorbablematerials may be used to form buttress material. Some non-limitingexamples of materials from which the buttress material may be madeinclude, but are not limited to, poly(lactic acid), poly (glycolicacid), poly (hydroxybutyrate), poly (phosphazine), polyesters,polyethylene glycols, polyethylene oxides, polyacrylamides,polyhydroxyethylmethylacrylate, polyvinylpyrrolidone, polyvinylalcohols, polyacrylic acid, polyacetate, polycaprolactone,polypropylene, aliphatic polyesters, glycerols, poly(amino acids),copoly (ether-esters), polyalkylene oxalates, polyamides, poly(iminocarbonates), polyalkylene oxalates, polyoxaesters,polyorthoesters, polyphosphazenes and copolymers, block copolymers,homopolymers, blends and/or combinations thereof, for example.

Natural biological polymers can be used in forming the buttressmaterial. Suitable natural biological polymers include, but are notlimited to, collagen, gelatin, fibrin, fibrinogen, elastin, keratin,albumin, hydroxyethyl cellulose, cellulose, oxidized cellulose,hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethylcellulose, chitan, chitosan, and/or combinations thereof, for example.Natural biological polymers may be combined with any of the otherpolymeric materials described herein to produce the buttress material.Collagen of human and/or animal origin, e.g., type I porcine or bovinecollagen, type I human collagen or type III human collagen may be usedto form the buttress material. The buttress material may be made fromdenatured collagen or collagen which has at least partially lost itshelical structure through heating or any other method, consisting mainlyof non-hydrated a chains, of molecular weight close to 100 kDa, forexample. The term “denatured collagen” means collagen which has lost itshelical structure. The collagen used for the porous layer as describedherein may be native collagen or atellocollagen, notably as obtainedthrough pepsin digestion and/or after moderate heating as definedpreviously, for example. The collagen may have been previouslychemically modified by oxidation, methylation, succinylation, ethylationand/or any other known process.

Where the buttress material is fibrous, the fibers may be filaments orthreads suitable for knitting or weaving or may be staple fibers, suchas those frequently used for preparing non-woven materials. The fibersmay be made from any biocompatible material. The fibers may be formedfrom a natural material or a synthetic material. The material from whichthe fibers are formed may be bioabsorbable or non-bioabsorbable. Itshould be understood that any combination of natural, synthetic,bioabsorbable and non-bioabsorbable materials may be used to form thefibers. Some non-limiting examples of materials from which the fibersmay be made include, but are not limited to, poly(lactic acid), poly(glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyesters,polyethylene glycols, polyethylene oxides, polyacrylamides,polyhydroxyethylmethylacrylate, polyvinylpyrrolidone, polyvinylalcohols, polyacrylic acid, polyacetate, polycaprolactone,polypropylene, aliphatic polyesters, glycerols, poly(amino acids),copoly (ether-esters), polyalkylene oxalates, polyam ides, poly(iminocarbonates), polyalkylene oxalates, polyoxaesters,polyorthoesters, polyphosphazenes and copolymers, block copolymers,homopolymers, blends and/or combinations thereof. Where the buttressmaterial is fibrous, the buttress material may be formed using anymethod suitable to forming fibrous structures including, but not limitedto, knitting, weaving, non-woven techniques and the like, for example.Where the buttress material is a foam, the porous layer may be formedusing any method suitable to forming a foam or sponge including, but notlimited to the lyophilization or freeze-drying of a composition, forexample.

The buttress material may possesses haemostatic properties. Illustrativeexamples of materials which may be used in providing the buttressmaterial with the capacity to assist in stopping bleeding or hemorrhageinclude, but are not limited to, poly(lactic acid), poly(glycolic acid),poly(hydroxybutyrate), poly(caprolactone), poly(dioxanone),polyalkyleneoxides, copoly(ether-esters), collagen, gelatin, thrombin,fibrin, fibrinogen, fibronectin, elastin, albumin, hemoglobin,ovalbumin, polysaccharides, hyaluronic acid, chondroitin sulfate,hydroxyethyl starch, hydroxyethyl cellulose, cellulose, oxidizedcellulose, hydroxypropyl cellulose, carboxyethyl cellulose,carboxymethyl cellulose, chitan, chitosan, agarose, maltose,maltodextrin, alginate, clotting factors, methacrylate, polyurethanes,cyanoacrylates, platelet agonists, vasoconstrictors, alum, calcium, RGDpeptides, proteins, protamine sulfate, epsilon amino caproic acid,ferric sulfate, ferric subsulfates, ferric chloride, zinc, zincchloride, aluminum chloride, aluminum sulfates, aluminum acetates,permanganates, tannins, bone wax, polyethylene glycols, fucans and/orcombinations thereof, for example. The use of natural biologicalpolymers, and in particular proteins, may be useful in forming buttressmaterial having haemostatic properties. Suitable natural biologicalpolymers include, but are not limited to, collagen, gelatin, fibrin,fibrinogen, elastin, keratin, albumin and/or combinations thereof, forexample. Natural biological polymers may be combined with any otherhaemostatic agent to produce the porous layer of the buttress. Theentire disclosure of U.S. Pat. No. 8,496,683, entitled BUTTRESS ANDSURGICAL STAPLING APPARATUS, which issued on Jul. 30, 2013, isincorporated by reference herein.

In various circumstances, the tissue thickness compensator assembly maycomprise a polymeric composition. The polymeric composition may compriseone or more synthetic polymer and/or one or more non-synthetic polymer.The synthetic polymer may comprise a synthetic absorbable polymer and/ora synthetic non-absorbable polymer. In various circumstances, thepolymeric composition may comprise a biocompatible foam, for example.The biocompatible foam may comprise a porous, open cell foam and/or aporous, closed cell foam, for example. The biocompatible foam can have auniform pore morphology or may have a gradient pore morphology (i.e.small pores gradually increasing in size to large pores across thethickness of the foam in one direction). In various circumstances, thepolymeric composition may comprise one or more of a porous scaffold, aporous matrix, a gel matrix, a hydrogel matrix, a solution matrix, afilamentous matrix, a tubular matrix, a composite matrix, a membranousmatrix, a biostable polymer, and a biodegradable polymer, andcombinations thereof. For example, the tissue thickness compensatorassembly may comprise a foam reinforced by a filamentous matrix or maycomprise a foam having an additional hydrogel layer that expands in thepresence of bodily fluids to further provide the compression on thetissue. In various circumstances, a tissue thickness compensatorassembly could also be comprised of a coating on a material and/or asecond or third layer that expands in the presence of bodily fluids tofurther provide the compression on the tissue. Such a layer could be ahydrogel that could be a synthetic and/or naturally derived material andcould be either biodurable and/or biodegradable, for example. In certaincircumstances, a tissue thickness compensator assembly could bereinforced with fibrous non-woven materials or fibrous mesh typeelements, for example, that can provide additional flexibility,stiffness, and/or strength. In various circumstances, a tissue thicknesscompensator assembly that has a porous morphology which exhibits agradient structure such as, for example, small pores on one surface andlarger pores on the other surface. Such morphology could be more optimalfor tissue in-growth or hemostatic behavior. Further, the gradient couldbe also compositional with a varying bio-absorption profile. A shortterm absorption profile may be preferred to address hemostasis while along term absorption profile may address better tissue healing withoutleakages.

Examples of non-synthetic polymers include, but are not limited to,lyophilized polysaccharide, glycoprotein, elastin, proteoglycan,gelatin, collagen, and oxidized regenerated cellulose (ORC). Examples ofsynthetic absorbable polymers include, but are not limited to,poly(lactic acid) (PLA), poly(L-lactic acid) (PLLA), polycaprolactone(PCL), polyglycolic acid (PGA), poly(trimethylene carbonate) (TMC),polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), acopolymer of glycolide and ε-caprolactone (PGCL), a copolymer ofglycolide and-trimethylene carbonate, poly(glycerol sebacate) (PGS),polydioxanone, poly(orthoesters), polyanhydrides, polysaccharides,poly(ester-am ides), tyrosine-based polyarylates, tyrosine-basedpolyiminocarbonates, tyrosine-based polycarbonates,poly(D,L-lactide-urethane), poly(B-hydroxybutyrate),poly(E-caprolactone), polyethyleneglycol (PEG),poly[bis(carboxylatophenoxy) phosphazene], poly(amino acids),pseudo-poly(amino acids), absorbable polyurethanes, and combinationsthereof. In various circumstances, the polymeric composition maycomprise from approximately 50% to approximately 90% by weight of thepolymeric composition of PLLA and approximately 50% to approximately 10%by weight of the polymeric composition of PCL, for example. In at leastone embodiment, the polymeric composition may comprise approximately 70%by weight of PLLA and approximately 30% by weight of PCL, for example.In various circumstances, the polymeric composition may comprise fromapproximately 55% to approximately 85% by weight of the polymericcomposition of PGA and 15% to 45% by weight of the polymeric compositionof PCL, for example. In at least one embodiment, the polymericcomposition may comprise approximately 65% by weight of PGA andapproximately 35% by weight of PCL, for example. In variouscircumstances, the polymeric composition may comprise from approximately90% to approximately 95% by weight of the polymeric composition of PGAand approximately 5% to approximately 10% by weight of the polymericcomposition of PLA, for example.

In various circumstances, the synthetic absorbable polymer may comprisea bioabsorbable, biocompatible elastomeric copolymer. Suitablebioabsorbable, biocompatible elastomeric copolymers include but are notlimited to copolymers of epsilon-caprolactone and glycolide (preferablyhaving a mole ratio of epsilon-caprolactone to glycolide of from about30:70 to about 70:30, preferably 35:65 to about 65:35, and morepreferably 45:55 to 35:65); elastomeric copolymers ofepsilon-caprolactone and lactide, including L-lactide, D-lactide blendsthereof or lactic acid copolymers (preferably having a mole ratio ofepsilon-caprolactone to lactide of from about 35:65 to about 65:35 andmore preferably 45:55 to 30:70) elastomeric copolymers of p-dioxanone(1,4-dioxan-2-one) and lactide including L-lactide, D-lactide and lacticacid (preferably having a mole ratio of p-dioxanone to lactide of fromabout 40:60 to about 60:40); elastomeric copolymers ofepsilon-caprolactone and p-dioxanone (preferably having a mole ratio ofepsilon-caprolactone to p-dioxanone of from about 30:70 to about 70:30);elastomeric copolymers of p-dioxanone and trimethylene carbonate(preferably having a mole ratio of p-dioxanone to trimethylene carbonateof from about 30:70 to about 70:30); elastomeric copolymers oftrimethylene carbonate and glycolide (preferably having a mole ratio oftrimethylene carbonate to glycolide of from about 30:70 to about 70:30);elastomeric copolymer of trimethylene carbonate and lactide includingL-lactide, D-lactide, blends thereof or lactic acid copolymers(preferably having a mole ratio of trimethylene carbonate to lactide offrom about 30:70 to about 70:30) and blends thereof. In one embodiment,the elastomeric copolymer is a copolymer of glycolide andepsilon-caprolactone. In another embodiment, the elastomeric copolymeris a copolymer of lactide and epsilon-caprolactone.

The disclosures of U.S. Pat. No. 5,468,253, entitled ELASTOMERIC MEDICALDEVICE, which issued on Nov. 21, 1995, and U.S. Pat. No. 6,325,810,entitled FOAM BUTTRESS FOR STAPLING APPARATUS, which issued on Dec. 4,2001, are hereby incorporated by reference in their respectiveentireties.

In various circumstances, the synthetic absorbable polymer may compriseone or more of 90/10 poly(glycolide-L-lactide) copolymer, commerciallyavailable from Ethicon, Inc. under the trade designation VICRYL(polyglactic 910), polyglycolide, commercially available from AmericanCyanamid Co. under the trade designation DEXON, polydioxanone,commercially available from Ethicon, Inc. under the trade designationPDS, poly(glycolide-trimethylene carbonate) random block copolymer,commercially available from American Cyanamid Co. under the tradedesignation MAXON, 75/25poly(glycolide-E-caprolactone-poliglecaprolactone 25) copolymer,commercially available from Ethicon under the trade designationMONOCRYL, for example.

Examples of synthetic non-absorbable polymers include, but are notlimited to, foamed polyurethane, polypropylene (PP), polyethylene (PE),polycarbonate, polyamides, such as nylon, polyvinylchloride (PVC),polymethylmetacrylate (PMMA), polystyrene (PS), polyester,polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE),polytrifluorochloroethylene (PTFCE), polyvinylfluoride (PVF),fluorinated ethylene propylene (FEP), polyacetal, polysulfone, andcombinations thereof. The synthetic non-absorbable polymers may include,but are not limited to, foamed elastomers and porous elastomers, suchas, for example, silicone, polyisoprene, and rubber. In variouscircumstances, the synthetic polymers may comprise expandedpolytetrafluoroethylene (ePTFE), commercially available from W. L. Gore& Associates, Inc. under the trade designation GORE-TEX Soft TissuePatch and co-polyetherester urethane foam commercially available fromPolyganics under the trade designation NASOPORE.

The polymeric composition of a tissue thickness compensator assembly maybe characterized by percent porosity, pore size, and/or hardness, forexample. In various circumstances, the polymeric composition may have apercent porosity from approximately 30% by volume to approximately 99%by volume, for example. In certain circumstances, the polymericcomposition may have a percent porosity from approximately 60% by volumeto approximately 98% by volume, for example. In various circumstances,the polymeric composition may have a percent porosity from approximately85% by volume to approximately 97% by volume, for example. In at leastone embodiment, the polymeric composition may comprise approximately 70%by weight of PLLA and approximately 30% by weight of PCL, for example,and can comprise approximately 90% porosity by volume, for example. Inat least one such embodiment, as a result, the polymeric compositionwould comprise approximately 10% copolymer by volume. In at least oneembodiment, the polymeric composition may comprise approximately 65% byweight of PGA and approximately 35% by weight of PCL, for example, andcan have a percent porosity from approximately 93% by volume toapproximately 95% by volume, for example. In various circumstances, thepolymeric composition may comprise a greater than 85% porosity byvolume. The polymeric composition may have a pore size fromapproximately 5 micrometers to approximately 2000 micrometers, forexample. In various circumstances, the polymeric composition may have apore size between approximately 10 micrometers to approximately 100micrometers, for example. In at least one such embodiment, the polymericcomposition can comprise a copolymer of PGA and PCL, for example. Incertain circumstances, the polymeric composition may have a pore sizebetween approximately 100 micrometers to approximately 1000 micrometers,for example. In at least one such embodiment, the polymeric compositioncan comprise a copolymer of PLLA and PCL, for example. According tocertain aspects, the hardness of a polymeric composition may beexpressed in terms of the Shore Hardness, which can defined as theresistance to permanent indentation of a material as determined with adurometer, such as a Shore Durometer. In order to assess the durometervalue for a given material, a pressure is applied to the material with adurometer indenter foot in accordance with ASTM procedure D2240-00,entitled, “Standard Test Method for Rubber Property-Durometer Hardness”,the entirety of which is incorporated herein by reference. The durometerindenter foot may be applied to the material for a sufficient period oftime, such as 15 seconds, for example, wherein a reading is then takenfrom the appropriate scale. Depending on the type of scale being used, areading of 0 can be obtained when the indenter foot completelypenetrates the material, and a reading of 100 can be obtained when nopenetration into the material occurs. This reading is dimensionless. Invarious circumstances, the durometer may be determined in accordancewith any suitable scale, such as Type A and/or Type OO scales, forexample, in accordance with ASTM D2240-00. In various circumstances, thepolymeric composition of a tissue thickness compensator assembly mayhave a Shore A hardness value from approximately 4 A to approximately 16A, for example, which is approximately 45 OO to approximately 65 OO onthe Shore OO range. In at least one such embodiment, the polymericcomposition can comprise a PLLA/PCL copolymer or a PGA/PCL copolymer,for example. In various circumstances, the polymeric composition of atissue thickness compensator assembly may have a Shore A Hardness valueof less than 15 A. In various circumstances, the polymeric compositionof a tissue thickness compensator assembly may have a Shore A Hardnessvalue of less than 10 A. In various circumstances, the polymericcomposition of a tissue thickness compensator assembly may have a ShoreA Hardness value of less than 5 A. In certain circumstances, thepolymeric material may have a Shore OO composition value fromapproximately 35 OO to approximately 75 OO, for example.

In various circumstances, the polymeric composition may have at leasttwo of the above-identified properties. In various circumstances, thepolymeric composition may have at least three of the above-identifiedproperties. The polymeric composition may have a porosity from 85% to97% by volume, a pore size from 5 micrometers to 2000 micrometers, and aShore A hardness value from 4 A to 16 A and Shore OO hardness value from45 OO to 65 OO, for example. In at least one embodiment, the polymericcomposition may comprise 70% by weight of the polymeric composition ofPLLA and 30% by weight of the polymeric composition of PCL having aporosity of 90% by volume, a pore size from 100 micrometers to 1000micrometers, and a Shore A hardness value from 4 A to 16 A and Shore OOhardness value from 45 OO to 65 OO, for example. In at least oneembodiment, the polymeric composition may comprise 65% by weight of thepolymeric composition of PGA and 35% by weight of the polymericcomposition of PCL having a porosity from 93% to 95% by volume, a poresize from 10 micrometers to 100 micrometers, and a Shore A hardnessvalue from 4 A to 16 A and Shore OO hardness value from 45 OO to 65 OO,for example.

In various circumstances, the polymeric composition may comprise apharmaceutically active agent. The polymeric composition may release atherapeutically effective amount of the pharmaceutically active agent.In various circumstances, the pharmaceutically active agent may bereleased as the polymeric composition is desorbed/absorbed. In variouscircumstances, the pharmaceutically active agent may be released intofluid, such as, for example, blood, passing over or through thepolymeric composition. Examples of pharmaceutically active agents mayinclude, but are not limited to, hemostatic agents and drugs, such as,for example, fibrin, thrombin, and oxidized regenerated cellulose (ORC);anti-inflammatory drugs, such as, for example, diclofenac, aspirin,naproxen, sulindac, and hydrocortisone; antibiotic and antimicrobialdrug or agents, such as, for example, triclosan, ionic silver,ampicillin, gentamicin, polymyxin B, chloramphenicol; and anticanceragents, such as, for example, cisplatin, mitomycin, adriamycin.

Various methods are disclosed herein for manufacturing a tissuethickness compensator. Such methods could be used to manufacture anysuitable layer for use with a fastener cartridge and/or a surgicalfastening instrument, for example. Such a layer can comprise a less thanone hundred percent dense composition which can be created utilizing anysuitable process. For instance, such processes can include, for example,extruding, injection molding, weaving, lyophilization, gas-foaming,and/or melt-blowing processes. Some processes may produce a foam whileother processes may not produce a foam; however, in any event, all suchembodiments are contemplated for use with all of the embodimentsdisclosed herein.

The entire disclosures of:

U.S. Pat. No. 5,403,312, entitled ELECTROSURGICAL HEMOSTATIC DEVICE,which issued on Apr. 4, 1995;

U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS, which issued on Feb. 21,2006;

U.S. Pat. No. 7,422,139, entitled MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK, which issued onSep. 9, 2008;

U.S. Pat. No. 7,464,849, entitled ELECTRO-MECHANICAL SURGICAL INSTRUMENTWITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS, which issued on Dec.16, 2008;

U.S. Pat. No. 7,670,334, entitled SURGICAL INSTRUMENT HAVING ANARTICULATING END EFFECTOR, which issued on Mar. 2, 2010;

U.S. Pat. No. 7,753,245, entitled SURGICAL STAPLING INSTRUMENTS, whichissued on Jul. 13, 2010;

U.S. Pat. No. 8,393,514, entitled SELECTIVELY ORIENTABLE IMPLANTABLEFASTENER CARTRIDGE, which issued on Mar. 12, 2013;

U.S. patent application Ser. No. 11/343,803, entitled SURGICALINSTRUMENT HAVING RECORDING CAPABILITIES; now U.S. Pat. No. 7,845,537;

U.S. patent application Ser. No. 12/031,573, entitled SURGICAL CUTTINGAND FASTENING INSTRUMENT HAVING RF ELECTRODES, filed Feb. 14, 2008;

U.S. patent application Ser. No. 12/031,873, entitled END EFFECTORS FORA SURGICAL CUTTING AND STAPLING INSTRUMENT, filed Feb. 15, 2008, nowU.S. Pat. No. 7,980,443;

U.S. patent application Ser. No. 12/235,782, entitled MOTOR-DRIVENSURGICAL CUTTING INSTRUMENT, now U.S. Pat. No. 8,210,411;

U.S. patent application Ser. No. 12/249,117, entitled POWERED SURGICALCUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM,now U.S. Pat. No. 8,608,045;

U.S. patent application Ser. No. 12/647,100, entitled MOTOR-DRIVENSURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROLASSEMBLY, filed Dec. 24, 2009; now U.S. Pat. No. 8,220,688;

U.S. patent application Ser. No. 12/893,461, entitled STAPLE CARTRIDGE,filed Sep. 29, 2012, now U.S. Pat. No. 8,733,613;

U.S. patent application Ser. No. 13/036,647, entitled SURGICAL STAPLINGINSTRUMENT, filed Feb. 28, 2011, now U.S. Pat. No. 8,561,870;

U.S. patent application Ser. No. 13/118,241, entitled SURGICAL STAPLINGINSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S. Pat.No. 9,072,535;

U.S. patent application Ser. No. 13/524,049, entitled ARTICULABLESURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, filed on Jun. 15, 2012;now U.S. Pat. No. 9,101,358;

U.S. patent application Ser. No. 13/800,025, entitled STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013; now U.S. Pat.No. 9,345,481;

U.S. patent application Ser. No. 13/800,067, entitled STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013; now U.S. PatentApplication Publication No. 2014/0263552;

U.S. Patent Application Publication No. 2007/0175955, entitled SURGICALCUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM,filed Jan. 31, 2006; and

U.S. Patent Application Publication No. 2010/0264194, entitled SURGICALSTAPLING INSTRUMENT WITH AN ARTICULABLE END EFFECTOR, filed Apr. 22,2010, now U.S. Pat. No. 8,308,040, are hereby incorporated by referenceherein.

Although the various embodiments of the devices have been describedherein in connection with certain disclosed embodiments, manymodifications and variations to those embodiments may be implemented.Also, where materials are disclosed for certain components, othermaterials may be used. Furthermore, according to various embodiments, asingle component may be replaced by multiple components, and multiplecomponents may be replaced by a single component, to perform a givenfunction or functions. The foregoing description and following claimsare intended to cover all such modification and variations.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

1-30. (canceled)
 31. A surgical end effector, comprising: an anvilcomprising a staple forming surface; a staple cartridge jaw comprising achannel; a cartridge body, comprising: a proximal end; a distal end; adeck comprising a tissue-supporting surface; and a plurality of staplecavities; a plurality of staples removably stored in said staplecavities; a firing member movable from a proximal position toward adistal position to eject said staples from said staple cavities during astaple firing stroke; a layer releasably attached to said cartridgebody, wherein said layer is positioned adjacent to saidtissue-supporting surface; and a layer retainer movable between a firstposition and a second position, wherein said layer retainer preventssaid layer from moving with respect to said cartridge body when saidlayer retainer is in said first position, and wherein said layer isreleased from said cartridge body when said layer retainer is in saidsecond position.
 32. The surgical end effector of claim 31, wherein saidlayer retainer is moved toward said staple forming surface as said layerretainer is moved from said first position toward said second position.33. The surgical end effector of claim 31, wherein said cartridge bodyfurther comprises a guide slot defined therein, wherein said guide slotis configured to closely receive said layer retainer, and wherein saidguide slot is configured to facilitate movement of said layer retainerbetween said first position and said second position.
 34. The surgicalend effector of claim 31, wherein said cartridge body further comprisesa longitudinal slot extending from said proximal end toward said distalend, and wherein said layer retainer is aligned with said longitudinalslot.
 35. The surgical end effector of claim 31, wherein said cartridgebody is replaceably seated in said channel of said staple cartridge jaw.36. An end effector for use with a surgical stapling instrument, whereinsaid end effector comprises: an anvil comprising a staple formingsurface; a staple cartridge, comprising: a proximal end; a distal end; adeck; and a plurality of staple cavities; a plurality of staplesremovably stored in said staple cavities; a firing member movable from aproximal position toward a distal position to eject said staples fromsaid staple cavities; a layer releasably attached to said staplecartridge; and a layer retainer movable between a first position and asecond position, wherein said layer retainer holds said layer to saidcartridge body when said layer retainer is in said first position, andwherein said layer is released from said cartridge body when said layerretainer is in said second position.
 37. The end effector of claim 36,wherein said layer retainer is moved toward said staple forming surfaceof said anvil as said layer retainer is moved from said first positiontoward said second position.
 38. The end effector of claim 36, whereinsaid layer retainer is moved away from said deck as said layer retaineris moved from said first position toward said second position.
 39. Theend effector of claim 36, wherein said firing member is configured tomotivate said layer retainer into said second position.
 40. A staplecartridge assembly for use with a surgical stapling instrument, whereinsaid staple cartridge assembly comprises: a cartridge body, comprising:a proximal end; a distal end; a deck; and a plurality of staplecavities; a plurality of staples removably stored in said staplecavities; a firing member movable from a proximal position toward adistal position to eject said staples from said staple cavities during astaple firing stroke; a layer releasably attached to said cartridgebody; and a layer retainer movable between a first position and a secondposition, wherein said layer retainer is engaged with said layer whensaid layer retainer is in said first position, and wherein said layerretainer is disengaged with said layer when said layer retainer is insaid second position.
 41. The staple cartridge assembly of claim 40,wherein said layer retainer prevents said layer from moving with respectto said cartridge body when said layer retainer is in said firstposition.
 42. The staple cartridge assembly of claim 40, wherein saidlayer retainer does not prevent said layer from moving with respect tosaid cartridge body when said layer retainer is in said second position.43. The staple cartridge assembly of claim 40, wherein said layerretainer is moved away from said deck as said layer retainer is movedfrom said first position toward said second position.
 44. The staplecartridge assembly of claim 40, wherein said firing member is configuredto motivate said layer retainer into said second position.
 45. Thestaple cartridge assembly of claim 40, wherein said layer retainerprevents said layer from being pushed distally by said firing member assaid firing member is moved distally during said staple firing strokewhen said layer retainer is in said first position.
 46. The staplecartridge assembly of claim 40, wherein said layer retainer resistsmovement of said layer during said staple firing stroke when said layerretainer is in said first position.